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Virginia Commonwealth University Stress Reduction Study

Virginia Commonwealth University Stress Reduction Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04190030
Enrollment
72
Registered
2019-12-09
Start date
2021-07-19
Completion date
2022-07-31
Last updated
2022-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stress

Keywords

Mindfulness

Brief summary

This research study seeks to understand how stress reduction training influences neural responses (brain activation) and behavior related to stress, including emotions and reactions to social conflict.

Detailed description

The full research project will be conducted over approximately 2-3 weeks, and will consist of two data collection sessions, one before and one after a 14-day stress reduction training course conducted via a smartphone that participants provide. This course entails instructor-facilitated stress reduction exercises previously shown to reduce stress and improve well-being. Participants will be randomly assigned to a mindfulness course or a cognitive reappraisal course. Both of these courses -mindfulness training (MT) and cognitive reappraisal training (RT) - involve expert-facilitated mental wellness techniques. MT emphasizes mindfulness-based techniques to reduce stress and promote wellbeing, whereas CT emphasizes reframing and reappraisal techniques to reduce stress and promote well-being.

Interventions

Participants will listen to 20-minute lessons each day for 14 days plus complete brief (3 to 10 minute) exercises daily via their personal smartphone. Each course will involve mental exercises to reduce stress in daily life, along with direct instruction from the course leader to help in learning and applying the stress reduction techniques.

BEHAVIORALmindfulness training

Participants will listen to 20-minute lessons each day for 14 days plus complete brief (3 to 10 minute) exercises daily via their personal smartphone. Each course will involve mental exercises to reduce stress in daily life, along with direct instruction from the course leader to help in learning and applying the stress reduction techniques.

Sponsors

Mind & Life Foundation
CollaboratorUNKNOWN
Virginia Commonwealth University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 88 Years
Healthy volunteers
Yes

Inclusion criteria

* Stable medication regiment for 8 weeks prior to enrollment if taking antidepressant or anxiolytic medications. (will not be advertised but screened) * Free of major, uncorrected sensory impairments and cognitive deficits * Free of a certain psychiatric disorders or history thereof; specifically, a new diagnosis of a (non-acute) medical or psychiatric condition within the last 3 months, report a hospitalization over the last 3 months, report current drug abuse (e.g., recreational drug use, alcohol intake in excess of 2 drinks per day). * Adults aged 18 - 55 years of age * Right hand dominant (will not be advertised but screened) * Personal SmartPhone (Android or iOS operating systems). * Naive to meditation practice (will not be advertised but screened) * At least a moderate level of perceived stress (scale score \> 5 on the 4-item Perceived Stress Scale (PSS; reflects above-average perceived stress)

Exclusion criteria

* left-handed * are unwilling or unable to complete study assessments or treatments * report a new diagnosis of a (non-acute) medical or psychiatric condition within the last 3 months * report a hospitalization over the last 3 months * report current drug abuse (e.g., recreational drug use, smoke more than � pack per day, alcohol intake in excess of 2 drinks per day) * are prisoners * no personal SmartPhone (Android or iOS operating systems)

Design outcomes

Primary

MeasureTime frameDescription
Functional near-infrared spectroscopy (fNIRS) hemodynamic signal changeBaseline and 16 weeksProportion of participants who show a statistically significant change in regional specificity, as measured by fNIRS-recorded blood oxygenation representing markers of emotion reactivity and regulation during observation of video stimuli.

Secondary

MeasureTime frameDescription
Change in disgust responseBaseline and 16 weeksThe Disgust subscale of the Discrete Emotions Questionnaire (DEQ) will be used to assess the extent to which participants experience specific emotions on a scale from 1 (not at all) to 7 (an extreme amount) in response to video stimuli. Lower scores indicate less disgust and more emotion downregulation. Higher scores would indicate more disgust and less emotion downregulation.
Change in fear responseBaseline and 16 weeksThe Fear subscale of the Discrete Emotions Questionnaire (DEQ) will be used to assess the extent to which participants experience specific emotions on a scale from 1 (not at all) to 7 (an extreme amount) in response to video stimuli. Lower scores indicate less fear and more emotion downregulation. Higher scores would indicate more fear and less emotion downregulation.
Change in anxiety responseBaseline and 16 weeksThe Anxiety subscale of the Discrete Emotions Questionnaire (DEQ) will be used to assess the extent to which participants experience specific emotions on a scale from 1 (not at all) to 7 (an extreme amount) in response to video stimuli. Lower scores indicate less anxiety and more emotion downregulation. Higher scores would indicate more anxiety and less emotion downregulation.
Change in anger responseBaseline and 16 weeksThe Anger subscale of the Discrete Emotions Questionnaire (DEQ) will be used to assess s the extent to which participants experience specific emotions on a scale from 1 (not at all) to 7 (an extreme amount) in response to video stimuli. Lower scores indicate less anger and more emotion downregulation. Higher scores would indicate more anger and less emotion downregulation.
Change in intergroup attitudesBaseline and 16 weeksThe Beliefs about Groups survey will be used to assess explicit intergroup attitudes. Participants answer 4 questions using a scale from 1 to 6. Higher scores indicate poorer attitude outcomes.
Behavioral willingness to participate in a dyad-based future experiment16 weeksNumber of participants who express willingness to participate in a dyad-based future experiment using a scale from 1 to 5. Higher scores indicate greater willingness or preference to participate.
Change in sadness responseBaseline and 16 weeksThe Sadness subscale of the Discrete Emotions Questionnaire (DEQ) will be used to assess the extent to which participants experience specific emotions on a scale from 1 (not at all) to 7 (an extreme amount) in response to video stimuli. Lower scores indicate less sadness and more emotion downregulation. Higher scores would indicate more sadness and less emotion downregulation.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026